Daiichi Sankyo enrolls first patients in phase III clinical programs for Mirogabalin

The phase 3 clinical program across Asia includes the REDUCER (An Asian, phase 3, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of DS-5565 in patients with diabetiC pEripheral neuRopathic pain followed by a 52-week open-label extension) study and the NEUCOURSE (An AsiaN, phasE 3, mUltiCenter, randomized, dOUble-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study which will evaluate investigational mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), respectively.

The phase 3 global ALDAY (A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Patients with Pain Associated with Fibromyalgia) clinical program is ongoing and will evaluate mirogabalin for the treatment of pain associated with fibromyalgia in three identical studies.

"Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating," said Lesley Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director of the Women’s Health Research Program, University of Cincinnati and lead investigator of the ALDAY program.

"New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life."

"We are pleased that our global clinical development program evaluating the efficacy and safety of mirogabalin continues to move forward and has progressed into phase 3," said Mahmoud Ghazzi, MD, PhD, Executive Vice President and Global Head of Development for Daiichi Sankyo.

"Daiichi Sankyo is committed to identifying and studying new medicines that could help improve the management of chronic pain for people with diabetic peripheral neuropathy, postherpetic neuralgia and pain associated with fibromyalgia."

The REDUCER study will last 14 weeks and is being conducted at approximately 200 centers in Japan, Taiwan and Korea.

The NEUCOURSE study will also last 14 weeks and is being conducted at approximately 200 centers in Japan, Taiwan, Korea, Singapore, Malaysia and Thailand. The studies will include about 750 patients each with either diabetic peripheral neuropathic pain or postherpetic neuralgia, respectively.

The objectives of the double-blind studies are to evaluate safety and efficacy of mirogabalin by comparing change in the average daily pain score (ADPS) from baseline to Week 14 in patients receiving a total daily dose of either 15 mg, 20 mg or 30 mg of mirogabalin versus placebo. Both studies will be followed by one-year open-label extension studies to assess long-term safety and efficacy of mirogabalin.

The ALDAY program is a large clinical phase 3 program evaluating mirogabalin for the treatment of pain associated with fibromyalgia, and includes three, randomized, double-blind, placebo- and active-controlled studies, and an open label safety study that will be carried out over the next three years.

Approximately 4,000 patients with pain associated with fibromyalgia will be enrolled at approximately 800 clinical centers at more than 40 countries worldwide. The primary objective of the studies in the ALDAY program is to compare change in weekly ADPS from baseline to Week 13 in patients receiving a total daily dose of either 15 mg or 30 mg of mirogabalin versus placebo.

Weekly ADPS is based on daily pain scores reported by the patient that best describes his or her worst pain over the previous 24 hours. The primary objective of the phase 3 open-label extension study is to assess the long-term safety of a total daily dose of mirogabalin 15 mg or mirogabalin 30 mg in patients with pain associated with fibromyalgia.